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Diclofenac sodium, the active ingredient in Voltaren Ampoules, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation. The intramuscular injection is used to treat a number of painful conditions including: 'Flare-ups' of joint or back pain Attacks of gout Pain caused by kidney stones Pain caused by injuries. Voltaren Ampoules can either be given as an injection into the muscle, or as a slow infusion into a vein. The intravenous infusion is used in hospitals to prevent or treat pain following an operation. Voltaren Ampoules are not suitable for children. How to use The usual dose is: Adults One or two ampoules (75 to 150 mg) each day for one or two days. Elderly Your doctor may give you a dose that is lower than the usual adult dose if you are elderly. Children Not suitable for children. Warnings and precautions Do not use Voltaren Ampules Talk to your doctor if: you think you may be allergic to diclofenac sodium, sodium metabisulphite, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of Voltaren Ampoules. (These are listed at the end of the leaflet.) Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, runny nose, skin rash or any other allergic type reaction you have now, or have ever had, a stomach (gastric) or duodenal (peptic) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces) you have had stomach or bowel problems after you have taken other NSAIDs you have heart, kidney or liver failure if you have established heart disease and/or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear bypass blockages if you have or have had problems with your blood circulation (peripheral arterial disease) You should also ask yourself these questions before having a Voltaren Ampules: Do you suffer from any bowel disorders including ulcerative colitis or Crohn's disease? Do you have kidney or liver problems, or are you elderly? Do you suffer from any blood or bleeding disorder? Do you have a condition called porphyria? Have you ever had asthma? Are you breastfeeding? Do you have angina, blood clots, high blood pressure, abnormally high levels of fat in your blood (raised cholesterol or raised triglycerides) Side Effects Some side effects can be serious Tell the doctor straight away if you notice: Sudden and crushing chest pain (signs of myocardial infarction or heart attack) Breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure) Sudden weakness or numbness in the face, arm or leg especially on one side of the body; sudden loss or disturbance of vision; sudden difficulty in speaking or ability to understand speech; sudden migraine-like headaches which happen for the first time, with or without disturbed vision. These symptoms can be an early sign of a stroke. Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick) Any sign of bleeding in the stomach or intestine, for example, when emptying your bowels, blood in vomit or black, tarry faeces Allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or blistering The side effects listed below have also been reported. Common side effects (These may affect between 1 and 10 in every 100 patients): Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind, loss of appetite Headache, dizziness, vertigo Skin rash or spots Raised levels of liver enzymes in the blood Injection site reactions, symptoms include redness, swelling, change in the skin colour, inflammation, pain, and hypersensitivity Storage Information Store below 30°C. Protect from light and heat. Drug Interactions Some medicines can interfere with your treatment. Tell your doctor or pharmacist if you are taking any of the following: Medicines to treat diabetes Anticoagulants (blood thinning tablets like warfarin) Diuretics (water tablets) Lithium (used to treat some mental problems) Methotrexate (for some inflammatory diseases and some cancers) Ciclosporin and tacrolimus (used to treat some inflammatory diseases and after transplants) Trimethoprim (a medicine used to prevent or treat urinary tract infections) Quinolone antibiotics (for infections) Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example aspirin or ibuprofen Mifepristone (a medicine used to terminate pregnancy) Cardiac glycosides (for example digoxin), used to treat heart problems Medicines known as SSRIs used to treat depression Oral steroids (an anti-inflammatory drug) Voriconazole (a medicine used to treat fungal infections). Phenytoin (a medicine used to treat seizures) Zidovudine. Ingredients The glass ampoules contain 75 mg of the active ingredient, diclofenac sodium, in solution.
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